Catalog Number

-

Brand Name

BioPure HX2

Version/Model Number

HX2P-11612XX

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FIP

Product Code Name

Subsystem, Water Purification

Public Device Record Key

1bdc481f-eed1-413f-93bc-861a57f3daa6

Public Version Date

February 26, 2021

Public Version Number

1

DI Record Publish Date

February 18, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-